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Tuesday, January 29, 2013

Are J&J shooting themselves in the hip?

J&J Failed Own Safety Test in Hip Design, Witness Says

Johnson & Johnson (JNJ) failed its own safety test in designing an all-metal hip implant and then changed the protocol instead of fixing the problem, a witness testified in the first of 10,000 lawsuits to go to trial.

George Samaras, a consultant, testified today for Loren Kransky, who is suing J&J for defective design and failure to warn over an ASR XL hip he had replaced last year. J&J recalled 93,000 ASR hips in 2010 after saying 12 percent failed within five years. Another witness today said Australian data last year showed the hip failed at a 44 percent rate after seven years. Analysts say the lawsuits could cost J&J billions of dollars.

Samaras told jurors in state court in Los Angeles that J&J’s DePuy unit failed the safety standard it set up for the ASR hip cup, in which a metal ball atop the femur rotates. He cited an internal document showing the ASR produced 16 times more chromium and cobalt debris in the body than another DePuy product. While DePuy’s review standards said the ASR should have failed, the company said it passed, Samaras said.

“It’s horrible practice,” said Samaras, a biomedical engineer who runs a consulting firm near Pueblo, Colorado. “That’s not what good engineers do. You are playing games with what the requirements for the device are.”

The company denies Kransky’s claims, including failure to warn, defective design and negligent recall. In his opening statement, Alexander Calfo, a lawyer for J&J, said the ASR was properly designed. He said claims by Kransky, 65, of elevated metal levels in his body can be traced to his many other health problems, including diabetes, coronary artery disease, high blood pressure, kidney disease, strokes and cancer.

Design Criteria

Samaras said DePuy’s original design criteria said the ASR had to be at least as good as predecessor devices at the company. When that failed, DePuy found other devices for comparisons that put the ASR in a more favorable light, he said.

“They changed the test,” Samaras said. “They didn’t do what they were supposed to do, which is change the design.”

Samaras appeared before John Baron, an epidemiologist at Dartmouth Medical School testified that Australian national registry data showed that the ASR XL failed at a rate of 22 percent after five years and 44 percent after seven years.

The five-year rate, he said, “hits you between the eyes.”

He also reviewed data from England, Wales and Sweden, concluding that the failure rate is “extraordinarily high.”

‘Higher Rate’

“The ASR XL total hip replacement fails at a much higher rate than a typical hip replacement,” Baron said.

On cross-examination, J&J attorney Michael Zellers suggested that the rate of replacement surgeries rose after the negative publicity surrounding the recall.

“A surgeon would not remove a hip without a good reason,” Baron said. “It would be far-fetched to say that publicity regarding possible problems would lead a clinician to remove a hip.”

Jurors also saw the videotaped testimony of Magnus Flett, who led a DePuy design team and oversaw a group conducting a so- called failure mode and effect analysis, or FMEA, of the cup.

Flett said DePuy scrapped efforts to redesign the ASR cup because of financial and business reasons. He said that DePuy never told surgeons that the ASR failed and required followup surgeries known as revisions at a rate that was eight times that of another company hip device, the Pinnacle.

“I don’t believe that was clinically relevant,” he said.

Flett also discussed a proposal to study the performance of the ASR against the Pinnacle, another metal-on-metal device.

‘Like Suicide’

“This study seems like suicide to me,” he said in a 2005 e-mail. Flett testified that he likened such a study to suicide because “it will prove that one is better than the other and they are both our products and that means one will be worse.”

He said DePuy stopped selling the ASR in late 2009.

“We didn’t see the sales of the product continuing the way we wanted, so we took it off the market,” Flett said.

Kransky’s lawyers claim the implanted metal cups didn’t stimulate ingrowth of surrounding bone, making them unstable in the hip. They also claim the shallow design of the ASR cups, in which a metal ball atop the femur rotates, led to toxic debris of cobalt and chromium ions in the bloodstream.

J&J, based in New Brunswick, New Jersey, recalled the hip devices after saying U.K. data showed the ASR failed in more than 12 percent of patients after five years. A lawyer for Kransky, Michael Kelly, told jurors in his opening statement that internal J&J documents show 37 percent of ASR hips failed after 4.6 years.

Montana Physician

After Samaras testified, jurors heard by videotape from Daniel C. Brooke, a physician who practices in Kransky’s home state of Montana. He testified about examining Kransky and discussing a surgery to replace the ASR hip he had implanted in December 2007. Kransky, a retired prison guard, had a so-called revision surgery to remove the device in February 2012.

Brooke said that Kransky’s levels of chromium and cobalt debris were “very alarming.” Kransky’s multiple medical problems led the doctor to believe he might not survive the surgery.

“Kransky was always honest with me,” Brooke said. “He was an old man with a whole constellation of problems going on. He didn’t want to have surgery. I think he thought it was going to kill him.”

To contact the reporters on this story: David Voreacos in Newark, New Jersey, at dvoreacos@bloomberg.net; Maurice Possley in Los Angeles at mauricepossley@gmail.com; Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net

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